Why it was recalled
Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Product description
papaverine phentolamine prostaglandin; 30/1.5 mg/40 mcg/mL; 5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
Lot numbers, UPCs & expiration codes
All lots
Where it was sold
CA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0704-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 15, 2016
- FDA report date
- Feb 24, 2016
- Quantity
- 5 ml
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Abbott's Compounding Pharmacy, Inc.
Original FDA data
Every field from FDA enforcement report D-0704-2016, exactly as published.
Show all FDA fields
- City
- Berkeley
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 73090
- Address
- 2320 Woolsey St
- Code information
- All lots
- Postal code
- 94705-1973
- Report date
- Feb 24, 2016
- Product type
- Drugs
- Recall number
- D-0704-2016
- Classification
- Class II
- Recalling firm
- Abbott's Compounding Pharmacy, Inc.
- Product quantity
- 5 ml
- Termination date
- Apr 6, 2017
- Reason for recall
- Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- papaverine phentolamine prostaglandin; 30/1.5 mg/40 mcg/mL; 5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
- Distribution pattern
- CA
- Recall initiation date
- Jan 15, 2016
- Initial firm notification
- Press Release
- Center classification date
- Feb 17, 2016